The document summarizes the status of revisions to Australia's Advertising Code for therapeutic goods. It outlines that the code is being updated following consultation to improve clarity and support for sanctions. A proposed 2018 code is expected in July 2018 but would not take effect until January 2019 to allow time to adjust. The summary also notes some differences between the draft code stakeholders saw for consultation and the expected 2018 version, including additional requirements for comparisons ads and direct marketing.

1. The new Advertising Code - where are we at?
Webinar
Leanne McCauley & Mick O’Connor
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch
Regulatory Practice and Support Division
12 June 2018

2. About the Advertising Code
• Advertising to the public for therapeutic goods MUST comply with
the Advertising Code
See the Therapeutic Goods Act 1989 - section 42DM (criminal
offence) and section 42DMA (civil penalties)
Current version is 2015 Code
• The Code is the cornerstone of the advertising framework
• Requires that advertising is socially responsible and does not
mislead or deceive the consumer.
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3. Changing the Advertising Code
• Multiple drivers to amend Code, including to improve:
– clarity
– objectivity of provisions (to support sanctions & penalties)
• Consultation on proposed Code and guidance closed 27 April 2018
• We have considered stakeholders concerns, including:
– need for a transition period
– issues with specific provisions
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4. Proposed transition arrangements for new Code
• Currently working to finalise 2018 Code
• Subject to agreement, 2018 Code is expected to be:
– made and registered before 1 July 2018, BUT
– commencement delayed until 1 January 2019
• Allows for advertisers to become familiar with 2018 Code
• Complaints about advertisements pre-approved prior to 1 January
2019 - assessed for compliance under 2015 Code
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5. Interim arrangements for Schedule 3 advertising
• 2015 Code will be amended for to allow use of the new
include S3 statement from 1 July 2018 :
ASK YOUR PHARMACIST—THEY MUST DECIDE IF THIS
PRODUCT IS RIGHT FOR YOU
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6. Differences – 2018 Code vs consultation draft (1)
• Following differences are: (not an exhaustive list)
• Requirements to be added for:
– Comparison ads must not claim or imply that comparators are
harmful or ineffectual
– Advertising must not include offer of a sample, with the exception
of key public health items (e.g. sunscreens, condoms)
• Direct/internet marketing requirements to be described as
What advertisements must contain if the physical product is not
available for examination at time of purchase
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7. Differences – 2018 Code vs consultation draft (2)
• Scientific representations
– Separating the requirements for cited research studies from the
requirements for scientific claims
• Testimonials – clarification to requirements and removal of
restriction on relatives providing testimonials
• Advertising to children
– clarification – advertising directed primarily to children
– ability to impose conditions on advertising for goods
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8. Differences – 2018 Code vs consultation draft (3)
• Provisions relating to Allergies (s.20), mandatory requirements
(s.11, s.12, s.13)
– revised to ensure that only messages critical to the consumer
when selecting a product for self-treatment need to be
‘prominently displayed’
• Prohibited representation definition – “…diagnosis (including
screening), monitoring, susceptibility or pre-disposition…’
• Minor changes/corrections to Schedule 1 – Price information
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9. Differences – 2018 Code vs consultation draft (4)
Proposed revised definition for s 28 – restricted representation:
…a form of a disease, condition, ailment or defect is a serious form if:
(a) it is medically accepted that the form requires diagnosis or treatment or
supervision by a suitably qualified healthcare professional – UNLESS the
form has been medically diagnosed and medically accepted as being
suitable for self-treatment and management; or
(b) there is a diagnostic (including screening), preventative, monitoring,
susceptibility or pre-disposition test available for the form (including a self-
administered test), and which requires medical interpretation or follow-up.
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10. 2018 Code guidance
• Will be updated to reflect changes to the 2018 Code
• Some feedback from Code consultation will also be addressed via
guidance, including clarifications about:
– how s.23 (Complementary medicines) applies if there are multiple
indications or therapeutic claims based on multiple traditions or
paradigms
– restricted representations
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11. Next steps
• Working to finalise Advertising Code
• Consultation on complaints handling – submissions being
assessed
• Public consultation on Code guidance – late June – August 2018
• Establishment of an advertising committee with external
representation – oversight of performance & Code currency
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12. Further information
• Slides from 23 May 2018 online - https://www.tga.gov.au/tga-
presentation-update-therapeutic-goods-advertising-reforms
• Further webinars/roadshows considered
• Subscribe to TGA website updates
• Contact
Advertising.Consultation@tga.gov.au
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13. Questions
• We will run through some of the questions received:
– at registration
– during the webinar
• Some questions may be taken on notice and addressed through:
– publication on the TGA website
– addressed in guidance (when released) and/or
– another webinar or event
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